Biodefense Vaccines
Biosafety Updates
Biosafety issues are central
to biodefense vaccine acquisition program. With a multitude of
complex product development activities, Biosafety requirements are
unique to each product development stages and facilities involved
in these activities. Dr. Rao is involved in a lead role in the
development, implementation, monitoring, reporting of biosafety and
environmental affairs for over half-dozen biodefense vaccine
candidates under various stages of development.
As part of these
activities, Dr. Rao and his team publish a monthly update. The
update covers latest developments in biosafety and environmental
regulations, latest technologies in biosafety and bioprocess
security, biotechnology risks and risk analysis. Third
volume of the publication is current, with each volume containing
12 issues.
An annual summary 2002
Highlights in Biosafety was published for the first time. The
monthly updates and annual highlights are distributed to a wide
community in government vaccine acquisition community,
biotechnology companies and entities involved in Bioterrorism
preparedness and response.
2002 Highlights in
Biosafety (covering Volume 2, Numbers 1-12)
2003 Monthly Biosafety and
Environmental Affairs Update (Volume 3, Numbers
1-12)
January 2003
Update
February 2003 Update
March 2003
Update
April 2003
Update
Highlights from the Biosafety Affairs April
2003 Update (Volume 3, Number 4)
* National Smallpox Vaccine in Pregnancy
Registry
* Safety Reporting Requirements-FDA Proposed Rule
* Project BioShield
* ICGEB Biosafety Unity Activity Report
* National Vaccine Advisory Committee Report
* CBER-to-CDER Authority Transfer
* Smart Dust
* FDA Workshop on Risk Assessment and Risk
Management
May 2003
Update
Highlights from the Biosafety Affairs May
2003 Update (Volume 3, Number 5)
* Implementation of
smallpox vaccination program
* Biosecurity workshop
* Anthrax genome unveiled
* Homeland portal inviting firms input
* Planning against Bioterrorism-Lessons from outbreak
studies
* FDA-Ideology over Science?
* New Emergency Operations Center
* Outlook for Biotech Sector
June 2003
Update
Highlights from
the Biosafety Affairs June 2003 Update (Volume 3, Number
6)
* WHO publish
Revised Laboratory Biosafety Manual
* Update: Adverse Events from Civilian Smallpox
Vaccination
* Transgenic Research Animals Disposal
Practices
* ICGEB Biosafety Outstation
* FDA: Pharmacokinetics in Patients With Impaired Hepatic
Function
* FDA and Lincoln Technologies Work on Safety Data
Mining
* Prions as Nanotech Building Tool
July 2003
Update
Highlights from the Biosafety Affairs July 2003 Update
(Volume 3, Number 7)
* New National Biocontainment Laboratory
* NIH-Private Sector Partnerships in Product
Commercialization
* New Anthrax Vaccine Enters Clinical Trials
* Actions Insufficient to Strengthen Human Subject
Protection
* Human Monkeypox Virus-Infection Control and Exposure
Management
* Cartanega Biosafety Protocol Poised To Go Effective
* Biosafety-Future Priorities for Research in
Healthcare
August 2003
Update
Highlights from the Biosafety
Affairs August 2003 Update (Volume 3, Number 8)
* Biocontainment --
Challenges to Biotechnology Industry
* Building Capacity for Bioterrorism Response
* Pre-packed Hospitals -- Hospital Biosafety Management?
* CDC Guidelines Inadequate for Inhalational Anthrax
Detection
* Anthology of Biosafety -- BSL4 Laboratories
* FDA Role in National Response to Zoonotic Diseases
* DoD Information Security -- Additional Measures
Required
September 2003
Update
Highlights from the Biosafety Affairs
September 2003 Update (Volume 3, Number 9)
* Strategic National
Stockpile
* GeneVault-Rapid Detection of Biowarfare Agents
* Capacity Building in Biosafety
* New ASM Guidelines for Agents of Bioterrorism
* Smallpox Vaccination-Adverse Events Update
* NIH Success in Technology Transfer Program
* FDA Strategic Plan to Protect Public Health
* Ready or Not?
* New EMEA Guidance on Use of Bovine Serum
October 2003
Update
Highlights from the Biosafety
Affairs October 2003 Update (Volume 3, Number 10)
* West Nile Virus Transmission
Through Blood Donations
* Joint Staff Integrated Vulnerability Assessment
* Risks Due to Virus-Resistant Transgenics
* Existing Gaps in Surveillance
Capabilities
* Fate and Transport of Resistant Genes in the
Environment
* "21st" Century" - Regulations
* LABS21 - "Whole Building" Perspective
* BioShield and Homeland Security Appropriations
Bill
November 2003
Update
Highlights from the Biosafety Affairs November 2003
Update (Volume 3, Number 11)
* New Biosafety Level-4
Facility
* Need For Improved Security at Plum Island
* Interaction of Biodefense Vaccines
* Public Health Response to Anthrax Incidence 2001
* Building Epidemiology Capacity
* Risk Management Tools for Stockpile Program
* Anthrax Vaccine Rights for the UK
* Grid Computing-Road to Smallpox Therapy?
December 2003 Update
Highlights from the Biosafety Affairs December 2003
Update (Volume 3, Number 12)
* Military
Smallpox Vaccination Program Review
* Mass Vaccination not Required in Smallpox Outbreak
* CDC Publishes the Select Agent Interim Final Rule
* USDA Temporary Permits to Handle “Select Agents”
* Interim Rule to Prevent Transmission of Monkeypox
* USDA Center for Veterinary Biologics Issues
* Hospitals Receive Isolation Units
* National Health Network Would Reduce Medical Errors
* U.S., Mexico Hold Joint Terrorism
Drill
Biodefense Vaccine Hazard
Assessment
Biologics
product hazard assessment is now increasingly used to establish
safety of a product under development. Requirement for such
an assessment arises from the fact that say for instance a vaccine
candidate is based on etiologic agents considered highly dangerous,
a hazard assessment may lead to establishing safety standards
during production, testing and clinical
trials.
Dr. Rao is involved in
biologics products-related hazard assessment, referred to as
Maximum Credible Event
Analysis as it applies to public health and general
environmental safety. More recently, Dr. Rao led hazard
assessment of a recombinant vaccine candidate for the Venezuelan
Equine Encephalitis (VEE) virus. Both published literature
and data collected from studies sponsored under the program was
used to conduct the hazard assessment of the etiologic agent and
vaccine candidates.
The recombinant Venezuelan Equine Encephalitis (VEE) vaccine
candidate constructed from the highly virulent infectious clone,
which is derived from the wild-type VEE strain IA/B virus.
Our analysis indicated numerous differences between vaccine
candidates and the wild-type virus under study.
The US Centers for
Diseases Control and Prevention (CDC) has classified VEE as a
potential agent for biological terrorism. Recently, the CDC,
in consultation with the USDA, performed a detailed review to
determine if the Select Agent Rule (Title 42 C.F.R. Part 73)
is applicable to the vaccine strains under the revised Public
Health Security and Bioterrorism Preparedness and Response Act of
2002. Analytical study results provided by Dr. Rao’s team
constituted part of the overall body of
evidence summarized by the CDC-USDA team of experts to determine the vaccine
strains under study excluded from the regulatory
requirements under the Select Agent Rule.
Biosafety and Biosecurity
Assessment
Operational Medicine Research
Program
Dr. Rao was the principal
scientist and project manager at the SAIC's Biomedical Sciences
Group, responsible for providing highly specialized technical
support for the U.S. Army's Operational Medicine
Research Program on ambulatory physiological monitoring
systems. Under these projects, novel biomedical technologies
developed for monitoring the physiological status of soldiers during
training under extreme environmental conditions as well as in
battlefield were evaluated for further investigations and
development of prototypes for testing and
evaluation.
Dr. Rao was the principal
investigator or program manager (under contract) supporting program and technology reviews for
several Army Operational Medicine Research
Program elements covering pharmacological reviews and enabling
technology applications in physiological status monitoring
systems:
Melatonin Pharmacologial
Review
Caffeine Pharmacological
Review
Blast overpressue
Review
Health Risk
Appraisal
Deployment toxicology
